"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
TOBI® was generally well tolerated during two clinical studies in 258 cystic fibrosis patients ranging in age from 6 to 48 years. Patients received TOBI® in alternating periods of 28 days on and 28 days off drug in addition to their standard cystic fibrosis therapy for a total of 24 weeks.
Voice alteration and tinnitus were the only adverse experiences reported by significantly more TOBI®treated patients. Thirty-three patients (13%) treated with TOBI® complained of voice alteration compared to 17 (7%) placebo patients. Voice alteration was more common in the on-drug periods.
Eight patients from the TOBI® group (3%) reported tinnitus compared to no placebo patients. All episodes were transient, resolved without discontinuation of the TOBI® treatment regimen, and were not associated with loss of hearing in audiograms. Tinnitus is one of the sentinel symptoms of cochlear toxicity, and patients with this symptom should be carefully monitored for high frequency hearing loss.
The numbers of patients reporting vestibular adverse experiences such as dizziness were similar in the TOBI® and placebo groups.
Nine (3%) patients in the TOBI® group and nine (3%) patients in the placebo group had increases in serum creatinine of at least 50% over baseline. In all nine patients in the TOBI® group, creatinine decreased at the next visit.
Table 1 lists the percent of patients with treatment-emergent adverse experiences (spontaneously reported and solicited) that occurred in > 5% of TOBI® patients during the two Phase III studies.
Table 1: Percent of Patients With Treatment Emergent
Adverse Experiences Occurring in > 5% of TOBI® Patients
|Lung Function Decreased2||16.3||15.3|
|Lower Respiratory Tract Infection||5.8||8.0|
|1Includes subjective complaints of fever.
2Includes reported decreases in pulmonary function tests or decreased lung volume on chest radiograph associated with intercurrent illness or study drug administration.
Adverse drug reactions ( < 5%) occurring more frequently with TOBI in the placebo-controlled studies and assessed as drug-related in ≥ 1% of patients:
Ear And Labyrinth Disorders
Tinnitus (3.1%, vs 0% for placebo)
Musculoskeletal And Connective Tissue Disorders
Myalgia (4.7%, vs 2.7% for placebo)
Infections And Infestations
Laryngitis (4.3%, vs 3.1% for placebo)
Adverse Drug Reactions Derived From Spontaneous Reports
The following adverse reactions have been identified during postapproval use of TOBI. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Ear And Labyrinth Disorders
Hearing loss (see WARNINGS – Ototoxicity)
Skin And Subcutaneous Tissue Disorders
Nervous System Disorders
Respiratory, Thoracic, And Mediastinal Disorders
Bronchospasm (see WARNINGS – Bronchospasm), oropharyngeal pain
Read the Tobi (tobramycin) Side Effects Center for a complete guide to possible side effects
In clinical studies of TOBI®, patients taking TOBI® concomitantly with dornase alfa (PULMOZYME® , Genentech), ß-agonists, inhaled corticosteroids, other anti-pseudomonal antibiotics, or parenteral aminoglycosides demonstrated adverse experience profiles similar to the study population as a whole.
Concurrent and/or sequential use of TOBI® with other drugs with neurotoxic, nephrotoxic, or ototoxic potential should be avoided. Some diuretics can enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue. TOBI® should not be administered concomitantly with ethacrynic acid, furosemide, urea, or intravenous mannitol. The interaction between inhaled mannitol and TOBI® has not been evaluated.
Read the Tobi Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 5/8/2014
This monograph has been modified to include the generic and brand name in many instances.
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